Study of INV-202 in Patients With Obesity and Metabolic Syndrome

Obesity Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of 3 Doses of INV-202 With an Optional Open-Label Extension in Patients With Obesity and Metabolic Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05891834
• Other study ID #: INV-CL-107
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 8, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2024
• Source: Inversago Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202 investigational drug in the treatment of adult participants with obesity and metabolic syndrome.

Description:

This will be a 2-part study. Part A will be a randomized, double-blind, placebo-controlled, dose ranging, multicenter study assessing the efficacy, safety, tolerability, and PK of INV-202 for the treatment of adult participants with obesity (BMI 30 kg/m2) and metabolic syndrome.

An informed consent form (ICF) must be signed by the participant before any study-related procedures are performed.

Each participant will be allowed 1 retest during the screening period if they have an abnormal test result not meeting eligibility criteria that is deemed transient by the investigator. Participants who did not meet all eligibility criteria may be re-screened once, with approval of the medical monitor.

Participants will return to the study site at Weeks 4, 8, 12 and 16. At these visits, the same assessment as baseline will be completed.

During Part A, a subset of approximately 20 to 30 participants from an estimated 3 to 4 study sites will have DEXA performed at baseline and Week 16 for exploratory assessments of change in total body fat percentage and skeletal muscle mass. Additional exploratory measures will include lung function with oscillometry. Any participant who withdraws from Part A before completing treatment will be requested to return for an early termination visit, at which time the procedures normally scheduled for the Week 16 visit will be conducted.

Participants completing Part A will be eligible to enroll to the open-label extension (OLE), Part B, if they did not have significant noncompliance with study drug, visits, or procedures, and did not meet any withdrawal criteria. During Part B, the efficacy and safety of INV-202 20 mg daily (pending results of chronic toxicology studies and/or findings from this and other ongoing clinical studies, the alternative dose would be 10 mg) will be further evaluated over an additional 36 weeks, through Week 52.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 243
• Est. completion date: March 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male and female participants from 18 to 75 years of age 2. Able and willing to provide informed consent and to comply with scheduled visits and study procedures 3. BMI = 30 kg/m2

4. Presence of at least 3 of the 5 following criteria at screening: i. Increased waist circumference (males, =40 inches; females, =35 inches) ii. Fasting glucose = 100 mg/dL in the last 3 months or an HgbA1C > 5.7% iii. Triglycerides = 150 mg/dL or 1.69 mmol/L iv. HDL < 40 mg/dL or 1.03 mmol/L for males or < 50 mg/dL or 1.29 mmol/L for females v. Hypertension (systolic >130 mmHg and/or diastolic > 85 mmHg) or treated for hypertension

Exclusion Criteria:

1. Significant medical condition, that in the opinion of the investigator, will place the participant at risk during the study or that will confound the study endpoints

2. Active substance abuse including inhaled, oral, or injection drugs in the past 12 months

3. Use of cannabis or cannabinoid-containing compounds within 90 days prior to screening

4. Pregnancy, planned pregnancy, potential for pregnancy, breast feeding, or unwillingness to use highly effective birth control during the study

5. History of significant liver disease or evidence of moderate to severe hepatic impairment

6. History of epilepsy or intracranial surgery

7. Diabetes requiring medication for management (a diagnosis of diabetes that is well controlled with diet and exercise is not exclusionary)

8. Bariatric surgery, use of a GLP-1 agonists or other weight-loss drug, or significant weight change (> 5 kg or 11 pounds) in the past 3 months

9. Participants taking any drug that may be used for weight loss (eg, liraglutide, semaglutide, tirzepatide, orlistat sibutramine phenylpropanolamine , mazindol , phentermine alone or in combination with topiramate, lorcaserin , naltrexone in combination with bupropion)

10. Use of systemic corticosteroids (topical and inhaled corticosteroids are not excluded)

11. Participants with an active diagnosis or history of a significant psychiatric disorder, including but not limited to the following:

Major depression within the last 2 years

• Any history of a suicide attempt or suicidal ideation

• A history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder)

• Taking any of the following medications: antidepressants, atypical antipsychotics and mood stabilizers such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, lithium

12. Score on the 9-question Patient Health Questionnaire (PHQ-9) of

13. Current or active malignancy within the past 5 years, except for cancer in situ, or nonmelanoma skin cancer, such as basal cell or squamous cell carcinoma that has been completely resected

14. A history thyroid disease; the only exception would be a participant who has undergone a complete thyroid ablation/resection

15. QTc > 500 ms at baseline

16. Any chronic medications with effects on blood pressure, lipids, or blood glucose started or changed within the past 3 months or at risk of requiring a change during the study

17. Participants taking a strong inducer or inhibitor of cytochrome P450 3A4, 2D6, or 2C19 by screening; these medications are prohibited during the entire duration of the study

18. Having taken any investigational compound within 30 days, or 5 half-lives of the drug, whichever is longer, before the screening visit

19. Previous use of INV-202

20. Participants that, in the opinion of the investigator, are unsuitable for the study or unlikely to comply with all study procedures and treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity
• Syndrome

Intervention

Drug:
• INV-202
tablet, once daily, oral
• Placebo
tablet, once daily, oral

Locations

Country	Name	City	State
Canada	Aggarwal and Associates, Limited	Brampton	Ontario
Canada	Ecogene-21	Chicoutimi	Quebec
Canada	Wharton Medical Clinic (WMC) - Toronto	Hamilton	Ontario
Canada	DIEX Research Joliette	Joliette	Quebec
Canada	Centricity Research - Levis	Lévis	Quebec
Canada	Milestone Research Inc	London	Ontario
Canada	Centricity Research - Mirabel	Mirabel	Quebec
Canada	9109-0126 Quebec Inc	Montréal	Quebec
Canada	Centricity Research -New Minas	New Minas	Nova Scotia
Canada	Office of David H. Shu, MD	New Westminster	British Colombia
Canada	Centricity Research - Oshawa	Oshawa	Ontario
Canada	Centricity Research - Pointe-Claire	Pointe-Claire	Quebec
Canada	Alpha Recherche Clinique - Lebourgneuf	Québec	Quebec
Canada	Alpha Recherche Clinique Val-Bélair	Québec	Quebec
Canada	Centre des maladies lipidique deq Quebec, CMLQ Inc.	Québec	Quebec
Canada	DIEX Research Quebec	Québec	Quebec
Canada	Bluewater Clinical Research Group Inc	Sarnia	Ontario
Canada	Diex Recherche Sherbrooke	Sherbrooke	Quebec
Canada	Canadian Phase Onward Inc.	Toronto	Ontario
Canada	Dr. Anil K. Gupta Medicine Professional Corporation	Toronto	Ontario
Canada	Diex Recherche Trois-Rivieres	Trois-Rivières	Quebec
Canada	Diex Recherche Victoriaville	Victoriaville	Quebec
Canada	Clinical Research Solutions	Waterloo	Ontario
Canada	Dr. Sameh Fikry Medicine Professional Corporation	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Inversago Pharma Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effect of INV-202 on body weight loss in participants with obesity and metabolic syndrome	Mean change from baseline in body weight at Week 16 for INV-202 versus placebo	Week 16
Secondary	To evaluate the effect of INV-202 on weight (marker of metabolic syndrome)	Mean percent change from baseline at each site visit for the following: Percent change in weight	Week 16
Secondary	To evaluate the effect of INV-202 on waist circumference (marker of metabolic syndrome)	Mean change from baseline at each site visit for the following: Change in waist circumference	Week 16
Secondary	To evaluate the effect of INV-202 on lipids (marker of metabolic syndrome)	Mean change from baseline at each site visit for the following: Change in lipids (LDL, VLDL, HDL, total cholesterol, ApoB) results by central laboratory testing	Week 16
Secondary	To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)	Mean change from baseline at each site visit for the following: Change in markers of glucose control (HgbA1C) results by central laboratory testing	Week 16
Secondary	To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)	Mean change from baseline at each site visit for the following: Change in markers of glucose control (insulin) results by central laboratory testing	Week 16
Secondary	To evaluate the effect of INV-202 on glucose control (marker of metabolic syndrome)	Mean change from baseline at each site visit for the following: Change in markers of glucose control (C-peptide) results by central laboratory testing	Week 16